Brief Summary

The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

770

participants targeted

Target at P75+ for all trials

Timeline

68mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach

4 countries

424 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.5 years study duration

Study Progress52%

Jun 2020Dec 2031

First Submitted

Initial submission to the registry

January 16, 2020

Completed

11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed

5 months until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed

10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

10.5 years

First QC Date

January 16, 2020

Last Update Submit

May 22, 2026

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (2)

Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)
Will assess the predictive performance of both primary markers separately. Time to first occurrence of worrisome features and/or high-risk stigmata will be measured from the time of baseline blood draw. Will use an overall significance level of 0.1. Will use a Bonferroni correction for multiplicity adjustment, the significance level applied to both primary biomarkers will be 0.05. Will evaluate using a two-sided log-rank test comparing time to occurrence of worrisome features and/or high-risk stigmata between the marker-positive and marker-negative subgroups. Will visually summarize time to occurrence of worrisome features and/or high-risk stigmata in both maker positive and marker negative using Kaplan-Meier curves. All biomarkers will come in with a predetermined threshold for determining marker positivity (as defined in their respective publications). The primary imaging marker is for MRI, the analysis of this biomarker will be restricted to participants with a pre-enrollment MRI.
Up to 5 years
Occurrence of an "unfavorable" outcome (PRIOR TO ADDENDUM #5 08/13/2024)
Defined as a composite of: (1) any pancreatic cancer without surgery; (2) unresectable pancreatic cancer or cancer \> T1a, N0 at surgery, and (3) benign disease at surgery will be approached from the intent-to-treat perspective. Time to the first occurrence of the primary endpoint will be measured from randomization. Survival analysis methods will be used to estimate and compare distributions of time to an unfavorable event between the study arms. In particular Kaplan-Meier estimates will be developed for each arm and a log rank test will be used to compare the two arms.
Up to 5 years

Secondary Outcomes (17)

Finding of a worrisome feature and/or high-risk stigmata on CT or MRI
Up to 5 years
Situational anxiety
Up to 5 years
Overall quality of life
Up to 5 years
Financial distress
Up to 5 years
Cost
Up to 5 years
+12 more secondary outcomes

Other Outcomes (1)

Predictive accuracy of radiomic markers for dysplasia and pancreatic cancer (PRIOR TO ADDENDUM #5 08/13/2024)
Up to 5 years

Study Arms (3)

Arm A (low intensity surveillance)

Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Endoscopic UltrasoundProcedure: Endoscopic Ultrasound-Guided Fine-Needle AspirationProcedure: Magnetic Resonance ImagingOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm B (high intensity surveillance)

Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with \>= 1 and \< 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with \>= 2 and \< 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst \>= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)

Observational

Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.

Interventions

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm A (low intensity surveillance)Arm B (high intensity surveillance)Observational

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm A (low intensity surveillance)Arm B (high intensity surveillance)Observational

Quality-of-Life AssessmentOTHER

Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)

Also known as: Quality of Life Assessment

Arm A (low intensity surveillance)Arm B (high intensity surveillance)

Questionnaire AdministrationOTHER

Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)

Arm A (low intensity surveillance)Arm B (high intensity surveillance)

Biopsy ProcedurePROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Arm A (low intensity surveillance)Arm B (high intensity surveillance)Observational

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm A (low intensity surveillance)Arm B (high intensity surveillance)Observational

Endoscopic UltrasoundPROCEDURE

Undergo EUS

Also known as: endosonography, EUS

Arm A (low intensity surveillance)Arm B (high intensity surveillance)Observational

Endoscopic Ultrasound-Guided Fine-Needle AspirationPROCEDURE

Undergo EUS-FNA

Also known as: endoscopic ultrasound-guided fine needle aspiration, EUS-FNA

Arm A (low intensity surveillance)Arm B (high intensity surveillance)Observational

Surgical ProcedurePROCEDURE

Undergo surgery

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Observational

Eligibility Criteria

Age50 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with pancreatic cysts.

You may qualify if:

Patient must be ≥ 50 years and ≤ 75 years of age
Patient must not have acute pancreatitis or a history of chronic pancreatitis
Patient must have received a CT, MRI, or EUS within 6 months prior to enrollment that revealed one or more ≥ 1 cm pancreatic cyst(s).
Patients of childbearing potential must not be known to be pregnant
Patient must not have a prior diagnosis of pancreatic malignancy of any type
Patient must not have a history of pancreatic resection
Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible
Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children)
Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥ 10mm, cyst causing obstructive jaundice)
Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection
Patient must not be in any form of pancreatic cyst surveillance for \> 1 year, defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest
PRIOR TO ADDENDUM #5 08/13/2024: Patient must be ≥ 50 years and ≤ 75 years of age
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have acute pancreatitis or a history of chronic pancreatitis.
PRIOR TO ADDENDUM #5 08/13/2024: Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).
PRIOR TO ADDENDUM #5 08/13/2024: Patients of childbearing potential must not be known to be pregnant.
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (424)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

RECRUITING

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

SUSPENDED

Alaska Breast Care and Surgery LLC